55c0f077-e365-1d95-e054-00144ff8d46c

SPL v3

SPL

SPL Set ID 55c0f077-e365-1d95-e054-00144ff8d46c

Route

topical

Published

Effective Date 2017-07-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

dimethicone (3.2 g)

Inactive Ingredients

sodium citrate polihexanide hydrochloride propylene glycol decyl glucoside allantoin water glycerin chlorphenesin bronopol polysorbate 20

Identifiers & Packaging

Marketing Status

otc monograph final active Since 2017-07-29

Purpose

Skin Protectant

Description

Dimethicone 3.2%

Medication Information

Purpose

Skin Protectant

Directions

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

Description

Dimethicone 3.2%

Use

provides temporary relief to irritated skin

Section 50565-1

Keep out of reach of children ,seek medical attention if swallowed

Section 51945-4

Warning

For external use only

Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

Active Ingredient

Dimethicone 3.2%

Inactive Ingredient

Aqua

Glycerin

Propylene Glycol

Polyaminopropyl Biguanide

Polysorbate 20

Allantoin

Chlorphenesin

Decyl Glucoside

2-Bromo-2-Nitropropane-1,3-Diol

Sodium Citrate

Structured Label Content

Purpose

Skin Protectant

Directions

peel back sticker

clean affected area with wipe

dispose of wipe properly

reseal label

Use

provides temporary relief to irritated skin

Section 50565-1 (50565-1)

Keep out of reach of children ,seek medical attention if swallowed

Section 51945-4 (51945-4)

Warning

For external use only

Do not use on

Large cuts or wounds

severe burns

eyes or near mouth

stop use and call a doctor if

symptoms last for greater than 7 days or reoccur after clearing up

Active Ingredient

Dimethicone 3.2%

Inactive Ingredient (INACTIVE INGREDIENT)

Aqua

Glycerin

Propylene Glycol

Polyaminopropyl Biguanide

Polysorbate 20

Allantoin

Chlorphenesin

Decyl Glucoside

2-Bromo-2-Nitropropane-1,3-Diol

Sodium Citrate

Advanced Ingredient Data

[{"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLIHEXANIDE HYDROCHLORIDE", "unii": "4XI6112496", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DECYL GLUCOSIDE", "unii": "Z17H97EA6Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "ACTIB", "strengthNumerator": "3.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BRONOPOL", "unii": "6PU1E16C9W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "provides temporary relief to irritated skin", "50565-1": "Keep out of reach of children ,seek medical attention if swallowed", "Purpose": "Skin Protectant", "Warning": "For external use only Do not use on Large cuts or wounds severe burns eyes or near mouth stop use and call a doctor if symptoms last for greater than 7 days or reoccur after clearing up", "Directions": "peel back sticker clean affected area with wipe dispose of wipe properly reseal label", "Active Ingredient": "Dimethicone 3.2%", "INACTIVE INGREDIENT": "Aqua Glycerin Propylene Glycol Polyaminopropyl Biguanide Polysorbate 20 Allantoin Chlorphenesin Decyl Glucoside 2-Bromo-2-Nitropropane-1,3-Diol Sodium Citrate"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:29.163469 · Updated: 2026-03-14T22:54:59.525683